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Value for money of medicine sampling and quality testing: evidence from Indonesia
Sara Valente de Almeida1, Katharina Hauck2, Sarah Njenga3
1Department of Infectious Disease Epidemiology, Imperial College London School of Public Health, London, UK svalente@ic.ac.uk.
Background:
Substandard and falsified medicines (SFMs) are a public health concern of global importance. Postmarket surveillance in the form of medicine sampling and quality testing can prevent and detect SFM, however, there is remarkably scarce evidence about the cost and value for money of these activities: how much do they cost and how effective are they in detecting SFM?
Methods:
Between February and October 2022, Systematic Tracking of At Risk Medicines (STARmeds) collected and analysed for quality 1274 samples of 5 medicines from physical and online retail outlets in 7 Indonesian districts. We collated data on the resources consumed by STARmeds, related to all stages of medicines sampling and quality testing including design, fieldwork and laboratory analysis. We used activity-based costing principles to calculate the financial and economic cost of medicine quality surveillance from the perspective of a hypothetical medicines' regulator. We calculated the cost per day and per week of fieldwork, per sample collected and per substandard sample. We used bootstrapping to capture uncertainty in the number of samples collected, by seller location type (urban, rural and online).
Results:
The total cost of sampling and testing medicines from the market was US$712 964 (current 2022 values). Laboratory costs represented the largest share (70%), followed by other direct costs (12%) and indirect costs (7%). On average, it costs STARmeds US$479 (95% CI US$462 to US$516) to collect one medicine sample and US$5990 (95% CI US$5601 to US$6258) to identify one substandard sample.
Conclusion:
Our findings bring urgently needed and novel information on the cost and value for money of medicine quality surveillance. These may support planning and budgeting of the Indonesian pharmaceutical regulator, but also of regulators and researchers elsewhere, particularly in low-income and middle-income settings, as well as international organisations with health regulation and quality of care remits.
Insights
Medicine quality surveillance is crucial for public health. This study found that identifying one substandard medicine sample costs approximately $5990, providing vital cost-effectiveness data for regulators.
Area of Science:
- Pharmacovigilance
- Health economics
- Pharmaceutical regulation
Background:
- Substandard and falsified medicines (SFMs) pose a significant global public health risk.
- Effective postmarket surveillance through medicine sampling and quality testing is essential for detecting SFMs.
- There is a critical lack of evidence regarding the cost and cost-effectiveness of medicine quality surveillance activities.
Purpose of the Study:
- To determine the financial and economic costs of medicine sampling and quality testing.
- To evaluate the cost-effectiveness of identifying substandard and falsified medicines (SFMs).
- To provide data supporting the planning and budgeting of pharmaceutical regulatory activities.
Main Methods:
- The Systematic Tracking of At Risk Medicines (STARmeds) initiative collected and analyzed 1274 medicine samples across 7 Indonesian districts.
- Activity-based costing principles were applied to calculate costs from a regulator's perspective.
- Bootstrapping was used to analyze costs per sample and per substandard sample, considering urban, rural, and online retail locations.
Main Results:
- The total cost for sampling and testing medicines was US$712,964.
- Laboratory analysis constituted the largest cost component (70%).
- The average cost to identify one substandard medicine sample was US$5990 (95% CI US$5601 to US$6258).
Conclusions:
- The study provides novel and essential data on the cost and value for money of medicine quality surveillance.
- Findings can inform resource allocation for the Indonesian pharmaceutical regulator and similar bodies globally, especially in low- and middle-income countries.
- This research supports international organizations focused on health regulation and quality of care.
